Kornimate/medical-research-clean huggingface dataset:
evaluation of different doses of letrozole in ectopic pregnancy

Conditions: Ectopic Pregnancy

Summary: the utilization of letrozole at a daily dose of 10 mg for medical treatment of ectopic pregnancy considerably has a high success rate without imposing any serious side effects compared to daily 5mg letrozole.

letrozole, an aromatase inhibitor, has recently been introduced as favorable medical treatment for ectopic pregnancy. we aimed at evaluating the effects of different doses of letrozole for induction of abortion sixty patients with undisturbed ectopic pregnancy were classified into three equal groups. group i: the control group that contained women who were undergoing laparoscopic salpingectomy, group ii: patients who received letrozole (5 mg d-1) for 10 d, and group iii: patients who received letrozole (10 mg d-1) for 10 d. after that, the human chorionic gonadotropin (β-hcg) levels were determined for the first day and after 11 d of treating. letrozole (10 mg d-1) markedly reduced the receptors of estrogen and progesterone, and subsequent vascular endothelial growth factor signals, resulting in marked apoptosis in the placenta tissue. the utilization of letrozole at a dose of 10 mg d-1 for inducement of abortion typically results in a substantial high-successful rate without any severe side effects.

Eligibility criteria:
inclusion criteria: * diagnosed ectopic pregnancy was by * absence of an intrauterine gestational sac on vaginal ultrasound coupled with * β-hcg titers beyond the discrimination zone of at least 2,000 milli-international units (miu/m). exclusion criteria: * patients had contraindications for letrozole * patients with any systemic disease ( diabetes, hypertension, ....) * patients with b-hcg levels \>3,000 miu/ml * patients with hemoglobin level \<10 g/dl, * patients with platelets count \<150,000/ml, * patients with elevated liver enzymes, * patients with elevated blood urea, or serum creatinine * the presence of a fetal heartbeat in a gestational sac detected outside the uterine cavity

Keywords: letrezole ectopic pregnancy induced abortion
development of new software capabilities for use with cardiovascular magnetic resonance imaging

Conditions: Abnormalities, Cardiovascular

Summary: this protocol is intended to facilitate development and testing of new cardiovascular mri software capabilities by uc davis research faculty, as well as to facilitate the evaluation of new software capabilities provided by ge and siemens.

this protocol will permit normal subjects, as well as patients with suspected or proven medical conditions, to undergo mri studies using the new software capabilities. this protocol is not restricted to imaging of a particular organ system or disease. the protocol does not involve injection of any contrast agent, or other minimally-invasive or invasive procedure. it is intended only for those cases for which the only requirement of the subject is to relax and lie still while imaging is being performed.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * ability to give informed, written consent * not pregnant or breastfeeding exclusion criteria: * electrically, magnetically, or mechanically activated implants (for example, cardiac-pacemakers) * ferromagnetic implant, such as an aneurysm clip, surgical clip, or prosthesis * history of uncontrolled claustrophobia

Keywords: mri
this is a study to evaluate the safety and tolerability of abl503, and to determine the maximum tolerated dose (mtd) and recommended phase 2 dose (rp2d) of abl503 in subjects with any progressive locally advanced or metastatic solid tumors

Conditions: Advanced Solid Tumor

Summary: this is a first-in-human phase 1, single-arm, open-label, multicenter, multiple-dose, dose-escalation and dose-expansion study of abl503 to evaluate the safety, tolerability, mtd and/or rp2d, pk, immunogenicity, preliminary antitumor activity, and the pd effect of abl503 in subjects with any progressive locally advanced (unresectable) or metastatic solid tumors who are relapsed or refractory following the last line of treatment and have no available standard of care option. this study includes 3 parts: a dose-escalation part, a dose-expansion part and tumor-expansion part


Eligibility criteria:
inclusion criteria: * histologically and/or cytologically confirmed diagnosis of any progressive locally advanced (unresectable) or metastatic solid tumors that have relapsed or are refractory following the last line of treatment, for which prior standard therapy has been ineffective, standard therapy does not exist, or is not considered appropriate. * with ae(s) excluding alopecia or grade 2 toxicities that are deemed stable or irreversible (eg, peripheral neuropathy) from prior therapy that have improved to grade 1 or the baseline grade more than 14 days prior to the first administration of the study drug * adequate hematologic, hepatic, and renal functions confirmed based on the screening laboratory tests and reconfirmed with additional safety laboratory tests performed within 72 hours prior to the first administration of abl503 exclusion criteria: * prior anticancer monoclonal antibody treatment or investigational therapy within 28 days prior to the first administration of study drug or has not recovered (ie, ≤ grade 1 or at baseline grade) from aes due to previously administered agent more than 14 days prior to abl503 administration * prior chemotherapy or radiation therapy within 2 weeks or targeted small molecule therapy within 5 half-lives prior to the first administration of study drug or has not recovered (ie, ≤ grade 1 or at baseline grade) from aes due to previously administered agent more than 14 days prior to abl503 administration * requiring or received systemic steroid therapy or any other immunosuppressive therapy within 14 days prior to study drug administration. * risk factors for bowel obstruction or bowel perforation (including but not limited to a history of acute diverticulitis, intra-abdominal abscess, and abdominal carcinomatosis. * discontinued from prior immunomodulatory therapy due to any intolerable immune-related adverse events (iraes) requiring systemic steroid treatment * history of drug-induced pneumonitis (interstitial lung disease) or currently has pneumonitis * received prior treatment with an anti-4-1bb antibody
strados system at center of excellence

Conditions: Copd; Asthma; Covid19

Summary: listening to breath sounds with the stethoscope/auscultation is used by pulmonary physicians in conjunction with pulmonary function, signs and symptoms, oxygen saturation and diagnostic testing to admit, follow and discharge patients from hospital. of these, only auscultation routinely ceases upon discharge from hospital. healthcare utilization statistics have shown that for more than a decade, readmission after discharge for an exacerbation of copd or severe asthma (or chronic heart failure) remains a major problem. the strados system has been designed to extend the range of lung sound recording both geographically and temporally to improve the standard of care when access to continuous monitoring has been replaced by periodic or no monitoring. the primary purpose of this study is to assess the clinical utility of the strados system in enabling periodic recording and reviewing of breath sounds in patients with chronic respiratory diseases, either in the icu, or in less continuously monitored settings, including after inpatient discharge.


Eligibility criteria:
inclusion criteria: potential study participants will be recruited from within the einstein center of excellence. individuals who meet all of the following criteria are eligible for enrollment as study participants: 1. males and females between the ages of 18-80: with documented physician-diagnosed copd (chronic bronchitis dominant) or severe asthma, as defined either by the american thoracic society or the world health organization who are admitted for exacerbation, including those with active or suspected sars-cov-2 infection or who are admitted with respiratory distress symptoms associated with sars-cov-2 infection 2. able to provide informed consent 3. able to follow study procedures 4. clinician assessment of the patient's current sars-cov-2 status: negative or unlikely to be infected, rtpcr positive, or untested by clinically suspected 5. accessible by telephone upon discharge exclusion criteria: subjects who meet any of the following criteria are not eligible for enrollment: 1. inability or unwillingness of the participant to give written informed consent 2. history of adverse reaction or allergy to tegaderm 3. unwillingness or inability to comply with study procedures 4. scheduled for thoracic procedure 5. inaccessible by telephone post-discharge
a study to determine the effect of nitroglycerin ointment 0.4% (cellegesic) on the pain associated with chronic anal fissures

Conditions: Fissure in Ano; Pain

Summary: anal fissure is a solitary ulcer in the squamous epithelium of the anus causing intense anal pain especially during defecation and for 1 or 2 hours afterwards. there are no approved drugs in the united states (us) for this condition and surgery is often the treatment choice. strakan is conducting this confirmatory study so the product can be submitted for regulatory approval in the us. strakan currently markets this product throughout europe. the objective of this study is to determine the effect of nitroglycerin ointment 0.4% (cellegesic) versus placebo on average pain intensity over every 24 hour period for up to 21 days of treatment in 250 patients.


Eligibility criteria:
inclusion criteria: * consenting patients of either sex. * between 18 and 75 years of age. * with a single, chronic, posterior midline anal fissure. * defined as having anal pain for the 6 weeks prior to screening. exclusion criteria: * more than one anal fissure. * a fistula-in-ano or anal abscess. * inflammatory bowel disease. * fibrotic anal stenosis. * anal fissure secondary to an underlying condition. * any anal surgery. * concomitant medication that may interfere with study evaluation.

Keywords: pain associated with chronic anal fissure
efficacy and safety of cerebrolysin on prolonged disorders of consciousness

Conditions: Disorder of Consciousness; Hemorrhagic Stroke

Summary: object: to determine the effect of cerebrolysin on prolonged disorders of consciousness caused by hemorrhagic stroke. participants: patients with prolonged disorders of consciousness due to severe traumatic brain injury intervention: 30 ml cerebrolysin + 70 ml normal saline, days 4-17, once/day, intravenously or 100 ml normal saline, days 4-17, once/day, iv comparison: cerebrolysin group versus control group outcome: coma recovery scale-revised, fdg-pet signal


Eligibility criteria:
inclusion criteria 1. patients with hemorrhagic stroke confirmed by ct or mri 2. patients who have been in disorders of consciousness for more than 4 weeks after the onset of hemorrhagic stroke 3. patients in a vegetative state or minimally conscious state (coma recovery scale -revised: crs-r assessment) 4. age: 19 to 80 years of age 5. patients who have voluntarily given written informed consent to participate in the study by themselves or their legal representative. exclusion criteria 1. patients with confirmed epileptiform discharges on eeg 2. patients with brain parenchymal defects 3. patients with advanced liver, kidney, cardiac, or pulmonary disease. 4. chronic treatment with medications that may affect consciousness, such as antidepressants, antipsychotic drugs, nootropic drugs, and vasodilators. 5. history of serious illness within the last two years (cancer, hematologic, renal, hepatic, or coronary artery disease, psychiatric illness, diabetes, myocardial infarction, epilepsy), no evidence of secondary damage to major organs, and well-controlled diabetes or hypertension. 6. alcohol or drug abuse or dependence within the last 2 years (dsm-v criteria). 7. significant systemic disease or unstable medical condition that may compromise compliance with the study protocol. 8. administration of a contraindicated drug is essential for medical purposes. 9. contraindications to the study drug (cerebrolysin). 10. participation in another therapeutic study
effectiveness of khat on eyelid wound healing after oculoplastic surgery - a prospective study.

Conditions: Hematoma; Surgical Wound; Surgery; Eye Bruise; Edema

Summary: the post operative routine after oculoplastic surgery includes usage of cold compressions for symptomatic relief and decreasing of the edema and local hematomas in the first few days after the surgery. khat (catha edulis) is a plant that is used mainly for chewing and has a known stimulating effect, some patients report major improvement after including these leaves in the compressions they use after surgery. khat contains the chemical ingredients cathine and cathinone, which are amphetamine-like alkaloids and probably the main contributors for its active effects. our main goal is to use compressions that include the khat leaves and check their effect on reducing the edema and hematomas after oculoplastic surgery.


Eligibility criteria:
inclusion criteria: * patients who underwent blepharoplasty and/or ptosis repair exclusion criteria: * patients who were operated on one eye only * patients who underwent a different surgery in each eye

Keywords: oculoplastic surgery khat leaves post operative care edema hematoma
effectiveness and safety study of the next-generation dexcom™ seven® continuous glucose monitoring system

Conditions: Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Summary: the purpose of this study is to evaluate the safety and effectiveness of the next-generation dexcom seven continuous glucose monitoring system (seven.2 system) when worn for up to 7-days by subjects \>18 years-old with diabetes mellitus requiring insulin therapy.


Eligibility criteria:
inclusion criteria: * age 18 years or older * have been diagnosed with insulin-requiring diabetes and are on multiple daily injections (mdi) or continuous subcutaneous insulin infusion (csii) insulin therapy * willing not to inject insulin or wear an insulin pump insertion set within 3 inches from the sensor site during sensor wear * willing to use only the blood glucose meter(s) provided to them for self-monitoring of blood glucose (smbg) during sensor wear * willing to participate in one, 8-hour in-clinic session and be willing to take 4 fingersticks per hour and have 4 blood draws per hour for the entire 8-hour duration * willing to take a minimum of 6 fingersticks per day during home use (2 for calibration purposes, 4 for comparative purposes) * willing to refrain from the use of acetaminophen during the sensor insertion period and for at least 24-hours prior to sensor insertion * willing not to schedule a magnetic resonance (mri) scan, computed tomography (ct) scan, or x-ray, for the duration of the study * able to speak, read, and write english exclusion criteria: * have extensive skin changes/diseases that preclude wearing the sensor on normal skin (e.g. extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, extensive tattoos, dermatitis herpetiformis) at the proposed wear sites * subjects who have a known allergy to medical-grade adhesives * are pregnant as demonstrated by a positive pregnancy test within 72 hours of insertion * have a hematocrit that is less than 30%, or greater than 55% * current participation in another investigational study protocol (if a subject has recently completed participation in another drug study, the subject must have completed that study at least 30 days prior to being enrolled in this study) * have any condition that, in the opinion of the investigator, would interfere with their participation in the trial or pose an excessive risk to study staff handling venous blood samples (e.g., known history of hepatitis b or c)

Keywords: continuous glucose monitoring interstitial fluid diabetes mellitus
safety and effectiveness of obg vs.a bandage contact lens for large corneal epithelial defects in patients post-prk.

Conditions: Corneal Epithelial Wound

Summary: this is a prospective, randomized (reading center), masked, controlled study in up to 45 subjects who have undergone bilateral prk with epithelial removal using alcohol in a 9.0 mm well or trephine at the time of surgery to ensure consistency of the size of the ablation area.

this is a prospective, randomized (reading center), masked, controlled study in up to 45 subjects who have undergone bilateral prk with epithelial removal using alcohol in a 9.0 mm well or trephine at the time of surgery to ensure consistency of the size of the ablation area. subjects will be assigned to one of three treatment arms on day 0.

Eligibility criteria:
inclusion criteria: * able and willing to comply with the protocol exclusion criteria: -

Keywords: photorefractive keratectomy, corneal defect
modified delphi for genomic bereavement care

Conditions: Fetal Anomaly; Bereavement; Genetic Disease

Summary: it is estimated that 1 in 4 pregnancies end in loss, be these early miscarriages, ectopic pregnancies, or later intrauterine losses for any reason. genomics is a major part of pregnancy loss, and clinicians want to offer the best and most appropriate test available to women and their families, whilst ensuring that there is equity in the access to this testing, so that no family goes through a loss without the right support and information. whilst there is limited information to inform professionals as to how to incorporate genomics into bereavement care there is a need to identify current expert consensus as to how this should be performed, in order to make recommendations for best practice.

there is a lack of guidance available as to how to care for women and families who suffer a pregnancy loss where fetal anomalies have been found and a genetic cause is suspected. as it is estimated that 1 in 4 pregnancies end in loss, these families make up a significant proportion of the population that maternity services care for and with no consensus in this area many families may have a poor experience. as the field of genomics rapidly advances, it is important that patient care reflects the changes in practice and that the most appropriate tests and support are offered. all aspects of patient care will be reviewed including diagnosis, delivery, laboratory investigations, postnatal care and follow up in future pregnancies. the role of the genomics midwife will be explored and the role of the bereavement midwife will be further defined when it comes to support following pregnancy loss where there is likely an underlying genomic cause. the aim of this modified delphi study is to understand what the current expert consensus is for genomic bereavement care. using this, best practice guidance will be written that can be used within the nhs to better support families who suffer pregnancy loss during this pregnancy and in the future.

Eligibility criteria:
inclusion criteria: * participants must belong to one of the relevant stakeholder groups; maternal and fetal medicine consultants or obstetricians with a special interest in fetal medicine, clinical geneticists with an interest in prenatal genomics, perinatal pathologists clinical scientists with an interest in genomics, bereavement midwives. exclusion criteria: * nil if inclusion criteria are met
prospective observational study of localized angiosarcoma of any site: prostars

Conditions: Angiosarcoma

Summary: this study will be a multi-institutional, prospective, observational study of patients with localized primary as of any site within isg and rtr centers. patients will be treated according to clinical practice of the center and according to isg clinical recommendations on localized as.

the management of localized as remains a clinical challenge and needs to be better defined and standardized, especially with regards to the role of radiation-therapy and systemic treatment. several questions about the best treatment approach to some clinical presentations remain open and would need to be answered by clinical studies. unfortunately, the rarity of this histology among sarcomas makes it challenging to carry out clinical studies in all such presentations. moreover, prognostic factors are lacking and differences in epidemiological, pathological and clinical aspects between primary as and secondary as need to be better characterized. these issues may be addressed with a prospective multi-institutional observational study, through the collection of clinical and pathological data of patients with localized as. involving all reference centres for sarcoma in italy, the italian sarcoma group (isg) will be the ideal network for this study, with the collaboration of the italian rare cancer network (rtr), a 7collaborative network among italian centres focusing on improving the quality of care of patients with rare tumors.

Eligibility criteria:
inclusion criteria: * pathological diagnosis of as; * any site of origin; * any age; * primary, localized, resectable disease. exclusion criteria: na
efficacy of omega-3 as adjunctive therapy for medically intractable epilepsy: a prospective open-label pilot study

Conditions: Epilepsy

Summary: the purpose of this study is to determine whether omega-3 is effective in the treatment of medically intractable epilepsy as adjunctive therapy.

this study will enroll total 30 patients with medically intractable epilepsy. the patients will be fully assessed on the enrollment, and then seizure frequency will be counted for three months without changing medication. after three months, omega-3 will be administered for next three months. seizure frequency, questionnaires evaluating mood and qol, and adverse events are evaluated at each visit.

Eligibility criteria:
inclusion criteria: * patients with medically intractable, focal or generalized, epilepsy: patients with localization-related partial onset or generalized tonic/clonic seizure according to the international league against epilepsy (ilae) can be included. medically intractable epilepsy means that recurrent seizures occur even though two or more anti-epileptic drugs have been used appropriately for over one year. * seizure frequency criteria: three seizures per one month for recent 3 months before enrollment * seizure criteria: simple partial, complex partial, or tonic-clonic seizures * subjects with normal cognitive function: patients who can perform normal daily life. if not definite, enrollment will be done with k-mmse score over 27. exclusion criteria: * poor general medical condition: comorbid with heart, lung, liver diseases * patients who have history of pseudo-seizure * anti-epileptic drugs has been changed in recent one month. * chronic alcoholic * seizure count cannot be done since seizures occur successively. * allergy to fish * high risk of bleeding such as trauma or operation * liver function abnormality * pregnant or lactating women, or women who plans to have children * patients who have participated in the other clinical trial in recent one month

Keywords: medically intractable epilepsy, omega-3